Tooth Extraction Status NosNCT06496906
Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems
A study testing Tooth extraction, Benex and Physics Forceps in people with Tooth Extraction Status Nos, run by Plovdiv Medical University at 1 site in Bulgaria.
Trial summary
The aim of the study is to compare the effectiveness of the vertical extraction system Benex and Physics forceps with the conventional extraction tools (extraction forceps and elevators) in the early wound healing period after tooth extraction, as means for minimally invasive tooth extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction Status Nos
- What is being tested?
- Tooth extraction, Benex and Physics Forceps
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Sep 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with teeth indicated for closed extraction
- Teeth with at least 1mm of tissue above the bone level
- Patients without contraindications for surgical intervention (ASA 1 or 2)
- Patients with good oral hygiene
Who cannot join
- Patients with severe systemic conditions or immunosuppression
- Teeth with mobility greater than Grade 1
- Teeth indicated for open surgical extraction
- Patients with acute odontogenic infections
- Drug or alcohol abuse
- Patients with psychiatric conditions
- Patients on anticoagulant or antiaggregant drugs refusing to undergo prior tests and preparation for tooth extraction
- Patients on chemotherapy, radiotherapy, or oral bisphosphonate intake
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Department of Oral Surgery, Faculty of Dental Medicine, Medical University - Plovdiv
Plovdiv, Pl, 4000
About this study
The aim of the study is to compare the effectiveness of the vertical extraction system Benex and Physics forceps with the conventional extraction tools (extraction forceps and elevators) in the early wound healing period after tooth extraction, as means for minimally invasive tooth extraction.
All patients aged 18 years and over who require closed tooth extraction with good oral hygiene were eligible for participation.
Participants were randomly allocated to tooth extraction with either Benex, Physics forceps or conventional extraction tools using box randomization. Patients are followed up during the recovery period to assess pain and early wound healing, while at the time of extraction, success and buccal cortical plate fracture were evaluated.
- Conditions
- Tooth Extraction Status Nos
- Being tested
- Tooth extraction, Benex, Physics Forceps, Conventional Extraction Forceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extractionProcedure or surgery
A regular closed tooth extraction was performed with the different devices from each arm.
BenexDevice
Benex was used to perform the intervention.
Physics ForcepsDevice
Physics forceps were used to perform the intervention.
Conventional Extraction ForcepsDevice
Conventional Extraction Forceps were used to perform the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Benex tooth extraction | Experimental | This is the first study group where patients undergo extractions with presumably the vertical tooth extraction system Benex. Receives: Procedure: Tooth extraction; Device: Benex |
| Physics forceps extraction | Experimental | This is the second study group where patients undergo extractions with the presumably minimally invasive Physics forceps. Receives: Procedure: Tooth extraction; Device: Physics Forceps |
| Convetional extraction | Active comparator | This is the control group where patients undergo tooth extractions with conventional extraction forceps and elevators. Receives: Procedure: Tooth extraction; Device: Conventional Extraction Forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extraction success
The scale suggested by Choi was used to assess each of the extraction systems.
Scored from 1 to 5. Higher is better.
Measured: From the beginning of the extraction to the completion of the procedure
Alveolar bone buccal cortical plate preservation
The difference between the height of the alveolar bone buccal cortical plate is measured before and after the tooth extraction.
Scored in milimeters missing. Lower is better.
Measured: From the beginning of the extraction to the completion of the procedure
VAS pain score
Patients were asked to rate their pain experience on a visual analog scale (VAS).
Measured in centimeters on 10cm line. Lower is better.
Measured: 0, 1, 3, 7 day
Early wound healing
Landry's early wound healing index was used to evaluated the extraction healing process.
Scores from 1 to 5. Higher is better.
Measured: 3, 7, 10 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Sep 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Status NosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496906
- Sponsor's protocol ID
- DPDP02/2021
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems
- ClinicalTrials.gov ID
- NCT06496906
- Acronym / sponsor ID
- DPDP02/2021
- Conditions
- Tooth Extraction Status Nos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare the effectiveness of the vertical extraction system Benex and Physics forceps with the conventional extraction tools (extraction forceps and elevators) in the early wound healing period after tooth extraction, as means for minimally invasive tooth extraction.
All patients aged 18 years and over who require closed tooth extraction with good oral hygiene were eligible for participation.
Participants were randomly allocated to tooth extraction with either Benex, Physics forceps or conventional extraction tools using box randomization. Patients are followed up during the recovery period to assess pain and early wound healing, while at the time of extraction, success and buccal cortical plate fracture were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Benex tooth extraction | Experimental | Procedure: Tooth extraction, Device: BenexThis is the first study group where patients undergo extractions with presumably the vertical tooth extraction system Benex. |
| Physics forceps extraction | Experimental | Procedure: Tooth extraction, Device: Physics ForcepsThis is the second study group where patients undergo extractions with the presumably minimally invasive Physics forceps. |
| Convetional extraction | Active comparator | Procedure: Tooth extraction, Device: Conventional Extraction ForcepsThis is the control group where patients undergo tooth extractions with conventional extraction forceps and elevators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with teeth indicated for closed extraction
- Teeth with at least 1mm of tissue above the bone level
- Patients without contraindications for surgical intervention (ASA 1 or 2)
- Patients with good oral hygiene
Key exclusion criteria (8 listed)
- Patients with severe systemic conditions or immunosuppression
- Teeth with mobility greater than Grade 1
- Teeth indicated for open surgical extraction
- Patients with acute odontogenic infections
- Drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth extractionA regular closed tooth extraction was performed with the different devices from each arm. | Procedure or surgery | Benex tooth extraction, Convetional extraction, Physics forceps extraction |
| BenexBenex was used to perform the intervention. | Device | Benex tooth extraction |
| Physics ForcepsPhysics forceps were used to perform the intervention. | Device | Physics forceps extraction |
| Conventional Extraction ForcepsConventional Extraction Forceps were used to perform the intervention. | Device | Convetional extraction |
Primary outcome
Extraction success
Time frame: From the beginning of the extraction to the completion of the procedure
The scale suggested by Choi was used to assess each of the extraction systems. Scored from 1 to 5. Higher is better.
Alveolar bone buccal cortical plate preservation
Time frame: From the beginning of the extraction to the completion of the procedure
The difference between the height of the alveolar bone buccal cortical plate is measured before and after the tooth extraction. Scored in milimeters missing. Lower is better.
VAS pain score
Time frame: 0, 1, 3, 7 day
Patients were asked to rate their pain experience on a visual analog scale (VAS). Measured in centimeters on 10cm line. Lower is better.
Early wound healing
Time frame: 3, 7, 10 day
Landry's early wound healing index was used to evaluated the extraction healing process. Scores from 1 to 5. Higher is better.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth extraction, Benex and Physics Forceps in people with Tooth Extraction Status Nos, run by Plovdiv Medical University at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extraction success (time frame: From the beginning of the extraction to the completion of the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.